[Federal Register Volume 71, Number 228 (Tuesday, November 28, 2006)]
[Rules and Regulations]
[Pages 68739-68740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-20111]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AM19


Medical: Informed Consent--Extension of Time Period and 
Modification of Witness Requirement for Signature Consent

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

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SUMMARY: This document adopts as a final rule the proposed rule 
amending the Department of Veterans Affairs (VA) medical regulations on 
informed consent. This final rule extends the period of time during 
which a signed consent form remains valid from 30 to 60 days and 
eliminates the requirement that a third-party witness the patient or 
surrogate and practitioner signing the consent form, except in those 
circumstances where the patient or surrogate signs with an ``X'' due to 
a debilitating illness or disability, i.e., significant physical 
impairment and/or difficulty in executing a signature due to an 
underlying health condition(s), or is unable to read and write.

DATES: Effective Date: December 28, 2006.

FOR FURTHER INFORMATION CONTACT: Ruth Cecire, PhD., Policy Analyst, 
Ethics Policy Service, National Center for Ethics in Health Care (10E), 
Veterans Health Administration, Department of Veterans Affairs, 810 
Vermont Avenue, NW., Washington, DC 20420; 202-501-2012 (this is not a 
toll-free number).

SUPPLEMENTARY INFORMATION: In a document published in the Federal 
Register on March 9, 2006 (71 FR 5204), VA proposed to amend its 
medical regulations at 38 CFR 17.32 on informed consent. Specifically, 
it proposed to extend the time during which a signed consent form is 
valid from 30 to 60 days. Also, it proposed to eliminate the 
requirement that a consent form be witnessed, except in those 
situations where the patient or surrogate signs with an ``X'' due to a 
debilitating illness or disability. VA provided a 60-day comment period 
that ended on May 6, 2006. No comments were received. Based on the 
rationale set forth in the proposed rule and those contained in this 
document, we are adopting the provisions of the proposed rule as a 
final rule without change.

Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 
1532, that agencies prepare an assessment of anticipated costs and 
benefits before issuing any rule that may result in an expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation) in any given year. This rule has no such effect on State, 
local, and tribal governments, or on the private sector.

Paperwork Reduction Act of 1995

    This rule contains no new collections of information under the 
Paperwork Reduction Act (44 U.S.C. 3501-3521). The existing information 
collections associated with the informed consent procedures under Sec.  
17.32 have been approved by the Office of Management and Budget (OMB) 
under 2900-0583.

Executive Order 12866

    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, when regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety, 
and other advantages; distributive impacts; and equity). The Order 
classifies a rule as a significant regulatory action requiring review 
by the Office of Management and Budget if it meets any one of a number 
of specified conditions, including: having an annual affect on the 
economy of $100 million or more, creating a serious inconsistency or 
interfering with an action of another agency, materially altering the 
budgetary impact of entitlements or the rights of entitlement 
recipients, or raising novel legal or policy issues. VA has examined 
the economic, legal, and policy implications of this final rule and 
concluded that it is a significant regulatory action because it raises 
novel policy issues.

Regulatory Flexibility Act

    The Secretary hereby certifies that this rule will not have a 
significant economic impact on a substantial number of small entities 
as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-
612. The rule will affect only individuals and will not directly affect 
any small entities. Therefore, pursuant to 5 U.S.C. 605(b), this rule 
is exempt from the initial and final regulatory flexibility analysis 
requirements of sections 603 and 604.

Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance numbers and titles for 
the programs affected by this document are 64.009, Veterans Medical 
Care Benefits; 64.010, Veterans Nursing Home Care; and 64.011, Veterans 
Dental Care.

List of Subjects in 38 CFR Part 17

    Administrative practice and procedure, Alcohol abuse, Alcoholism, 
Claims, Day care, Dental health, Drug abuse, Foreign relations, 
Government contracts, Grant programs-health, Grant programs-veterans, 
Health care, Health facilities, Health professions, Health records, 
Homeless, Medical and dental schools, Medical devices, Medical 
research, Mental health programs, Nursing homes, Philippines, Reporting 
and recordkeeping requirements, Scholarships and fellowships, Travel 
and transportation expenses, Veterans.

    Approved: October 23, 2006.
Gordon H. Mansfield,
Deputy Secretary of Veterans Affairs.

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For the reasons set out in the preamble, VA amends 38 CFR part 17 to 
read as follows:

[[Page 68740]]

PART 17--MEDICAL

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1. The authority citation for part 17 continues to read as follows:

    Authority: 38 U.S.C. 501, 1721, and as stated in specific 
sections.


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2. Section 17.32 is amended by:
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a. Revising the section heading.
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b. In paragraph (a), in the definition of signature consent, removing 
``, e.g., a published numbered VA form (OF 522) or comparable form 
approved by the local VA facility''.
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c. Revising paragraph (d)(2).
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d. Revising the authority citation at the end of the section.
    The revisions read as follows:


Sec.  17.32  Informed consent and advance care planning.

* * * * *
    (d) * * *
    (2) A patient or surrogate will sign with an ``X'' when the patient 
or surrogate has a debilitating illness or disability, i.e., 
significant physical impairment and/or difficulty in executing a 
signature due to an underlying health condition(s), or is unable to 
read and write. When the patient's or surrogate's signature is 
indicated by an ``X,'' two adults must witness the act of signing. By 
signing, the witnesses are attesting only to the fact that they saw the 
patient or surrogate and the practitioner sign the form. The signed 
form must be filed in the patient's medical record. A properly executed 
VA-authorized consent form is valid for a period of 60 calendar days. 
If, however, the treatment plan involves multiple treatments or 
procedures, it will not be necessary to repeat the informed consent 
discussion and documentation so long as the course of treatment 
proceeds as planned, even if treatment extends beyond the 60-day 
period. If there is a change in the patient's condition that might 
alter the diagnostic or therapeutic decision, the consent is 
automatically rescinded.
* * * * *
(Authority: 38 U.S.C. 7331-7334)

 [FR Doc. E6-20111 Filed 11-27-06; 8:45 am]
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